Pfizer scores FDA nod for biosim to AbbVie's Humira, but it'll have to wait till 2023 to launch

Pfizer
Pfizer is planning three biosim launches for the next few months. (Pfizer)

AbbVie is preparing for the costly U.S. loss of Humira exclusivity in 2023, and now there’s another pharma giant that has scored a biosimilar nod.

Pfizer’s Abrilada, a biosim to AbbVie’s megablockbuster Humira, won FDA approval Monday, becoming the 25th biosim to score a green light from the agency. And like many in that group, Abrilada will have to wait to launch due to patent issues. 

Pfizer last November inked a patent deal with AbbVie to allow for a 2023 biosimilar launch, joining other companies in making patent settlements with AbbVie rather than litigating a complex web of patents.

Webinar

De-risking the Development of Biotherapeutics Using Early Stage In Vitro Expression and Genetic Characterisation Tools

Wednesday, July 8, 2020 | 11am EST / 8am PST

This webinar will describe strategies to mitigate risks, reduce attrition and help improve the quality and safety of your drug candidate.

Abrilada won FDA approval to treat various inflammatory diseases treated by Humira. The company said it’ll provide more details about launch plans as the rollout nears. Meanwhile, the company has three biosim launches set for the next few months, CEO Albert Bourla said on a recent conference call. Pfizer plans to take on a trio of Roche drugs, launching its Avastin biosimilar on Dec. 31, followed by its Rituxan biosim in January and its Herceptin biosim in February.

RELATED: AbbVie inks Humira patent deal No. 7, delaying Pfizer's U.S. biosim launch until late 2023 

Under AbbVie’s existing patent deals with copycats, Amgen will have the chance to launch the first U.S. Humira biosimilar in 2023.  

Meanwhile, Humira biosims to the drug are already rolling in Europe, stealing market share and driving prices lower. AbbVie generated nearly $20 billion in Humira sales last year, and the drugmaker has agreed to acquire Allergan to shore up its future beyond the med’s U.S. loss of exclusivity.  

Read more on

Suggested Articles

Johnson & Johnson has expanded its COVID-19 vaccine production pact with CDMO Catalent to include work at the manufacturer's Anagni, Italy site.

German vaccine maker CureVac scored an $85 million EU loan to expand manufacturing for its mRNA-based COVID-19 vaccine hopeful.

Learn how drug substance and drug product early development strategies are important for optimization and long-term success.